Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients
Information source: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Microalbuminuria
Intervention: aspirin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hospital de Clinicas de Porto Alegre Official(s) and/or principal investigator(s): Eduardo G Camargo, Study Director, Affiliation: Programa de Pós-graduação em Ciências Médicas: Endocrinologia
Overall contact: Sandra P Silveiro, Phone: 55 51 33325188, Email: sandrasilveiro@terra.com.br
Summary
Research design: randomized, double-blind, placebo-controlled crossover study to evaluate
the putative interference of low-dose aspirin (for 8 weeks) on enalapril antiproteinuric
properties in microalbuminuric type 2 diabetes mellitus patients
Clinical Details
Official title: Aspirin and the Antiproteinuric Effect of Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients: a Randomized, Double-Blind, Placebo-Controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: urinary albumin excretionglomerular filtration rate
Detailed description:
Research design: randomized, double-blind, placebo-controlled crossover study Patients:
Microalbuminuric (urinary albumin excretion [UAE]30-300 mg/d)type 2 diabetes mellitus
patients without ischemic heart disease or peptic ulcer Aim: To evaluate the putative
interference of low-dose aspirin (300 mg/d)for 8 weeks)on enalapril antiproteinuric
properties in microalbuminuric type 2 diabetes mellitus patients Study protocol: Crossover
randomization to 8 weeks of enalapril 10 mg/d plus aspirin (300 mg/d) or plus placebo, and a
6-week washout period. Measurement of UAE (immunoturbidimetry) and glomerular filtration
rate (51Cr-EDTA), blood pressure and metabolic control at baseline and at the end of each
period.
Statistical analyses: Bland&Altman analyses for crossover trials.
Eligibility
Minimum age: 30 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- type 2 diabetes mellitus microalbuminuria
Exclusion Criteria:
- ischemic heart disease peptic disease
Locations and Contacts
Sandra P Silveiro, Phone: 55 51 33325188, Email: sandrasilveiro@terra.com.br
Hospital de Clínicas de Porto Aelgre, Porto Alegre, RS 900035900, Brazil; Recruiting Sandra P Silveiro, MD, Phone: 55 51 33325188, Email: sandrasilveiro@terra.com.br Sandra P Silveiro, MD, Principal Investigator Eduardo G Camargo, MD, Sub-Investigator
Additional Information
Starting date: March 2003
Last updated: January 26, 2007
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